EXTON, Pa. and DURHAM, N.C., Sept. 28, 2022 (GLOBE NEWSWIRE) — Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced it has completed the acquisition of Aceragen, Inc., a privately-held biotechnology company addressing rare, orphan pulmonary and rheumatic diseases for which there are limited or no available treatments. The combined cash of the two companies is expected to provide runway into Q3 2023, funding the advancement of Aceragen’s pipeline, including ACG-701 and ACG-801, through important 2023 clinical milestones. The Company estimates annual peak sales potential of $650 million from the three current lead programs.
About ACG-701 for Cystic Fibrosis and Melioidosis
ACG-701 is a proprietary formulation of sodium fusidate being developed as a potential treatment for acute pulmonary exacerbations (“PEx”) associated with cystic fibrosis (“CF”) and for melioidosis, a life-threatening infection caused by the B. pseudomallei pathogen.
The Phase 2 trial of ACG-701 in CF PEx (the REPRIEVE study) is expected to begin in Q4 2022 and is funded in part by an award from the Cystic Fibrosis Foundation. If approved, ACG-701 would represent the first product in the United States indicated for the treatment of CF PEx, a major factor behind lung function decline in patients living with CF. Data from the REPRIEVE study is expected in Q2 2023. The active component of ACG-701, sodium fusidate, has never been approved in the United States, but has been used for 50+ years with an established clinical efficacy and safety profile ex-US, including as part of CF PEx treatment guidelines in the United Kingdom and Australia. The FDA has assigned Orphan, Fast Track, and Qualified Infectious Disease Product status to ACG-701 for CF PEx.
The melioidosis clinical program for ACG-701 is supported by $51 million in funding from the Defense Threat Reduction Agency (“DTRA”) due to its potential use as a medical countermeasure. This trial, the TERRA study (NCT05105035), is underway and is targeting an interim analysis in Q1 2023; complete Phase 2 data is expected in Q2 2023. If approved for this indication, ACG-701 is anticipated to be eligible for a priority review voucher (“PRV”) and a national stockpiling contract.
About ACG-801 for Farber Disease
ACG-801, recombinant human acid ceramidase, is an investigational biologic enzyme replacement therapy being developed for the treatment of Farber disease, a lysosomal storage disorder and progressive rare disease with profound morbidity and often premature death. Acid ceramidase acts in the lysosome to metabolize ceramide, a pro-inflammatory lipid. Loss of acid ceramidase function leads to abnormal accumulation of ceramide, causing macrophage-driven inflammation and multi-organ disease affecting bone, cartilage, the immune system, central nervous system, and the lungs. There are no Farber disease-specific treatments currently available that can alter the natural history of the disease.
The Company expects to initiate the ADVANCE clinical study for ACG-801 in Farber disease in Q1 2023 with data expected in Q1 2024. Due to the ultra-rare nature of Farber disease, this study has the potential to be registrational. The FDA has granted Orphan, Fast Track, and Rare Pediatric Disease designations for ACG-801, which is also anticipated to be eligible for a PRV.
“After a thorough evaluation of strategic alternatives, we and our Board of Directors believe this acquisition represents the highest potential value creation opportunity for Idera’s stockholders,” said Vincent Milano, Idera’s former Chief Executive Officer and newly appointed Chair of the Board. “We are excited by the potential for Aceragen’s rare disease portfolio to result in meaningful therapeutic options for patients, and I am looking forward to being part of this new stage of Idera’s journey.”
Added John Taylor, Idera’s newly appointed Chief Executive, “This is an important transition for Aceragen. We are delighted to complement Aceragen’s exciting rare disease programs and dedicated team with financial resources, corporate structure, and people from Idera, better enabling us to deliver important therapies for patients living with rare diseases.”
Management and Organization
Vincent Milano, Idera’s former Chief Executive Officer, has been named Chair of the Board of Directors for the Company. He has been succeeded by John Taylor, the former Chief Executive Officer of Aceragen. Additional management team members of the combined Company include John Kirby, who will continue in his role as Idera’s Chief Financial Officer; Carl Kraus, Aceragen’s former Chief Medical Officer, who will serve in that role for Idera; Bryant Lim, who will continue in his role as Idera’s Chief Business Officer and General Counsel; Daniel Salain, Aceragen’s former Chief Operating Officer, who will serve in that role for Idera; and Andy Jordan, Aceragen’s former Chief Financial Officer, who has been appointed Chief Strategy Officer for Idera.
In conjunction with the transaction and with the appointment of Vincent Milano as Chair of the Board of Directors, Michael Dougherty, Idera’s former Chair of the Board, will remain an independent Board member of the combined company. Additional Board members include current Idera Board members Cristina Csimma, Pharm. D., M.H.P., James Geraghty, and Maxine Gowen, Ph.D., along with John Taylor and Ron Wooten, Founder and Managing Partner, NovaQuest Capital Management LLC. Mr. Taylor and Mr. Wooten previously served on Aceragen’s board.
About the Transaction
The acquisition of Aceragen was structured as a stock-for-stock transaction whereby all Aceragen outstanding equity interests were exchanged for a combination of shares of Idera common stock, shares of newly designated convertible Series Z preferred stock, and shares of the newly designated Series X preferred stock. Subject to stockholder approval of the conversion and an increase in authorized shares, each share of Series Z preferred stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. Holders of Series X preferred stock are entitled to receive distributions on shares of Series X preferred stock. On a pro forma basis and based upon the number of shares of Idera common stock and preferred stock issued in the acquisition, Idera equity holders immediately prior to the acquisition will own approximately 33% of the combined Company (on an as-converted, fully-diluted basis and excluding certain out-of-the-money options and warrants held by Idera’s equity holders) immediately after these transactions. The acquisition was unanimously approved by the Board of Directors of Idera and the Board of Directors of Aceragen. The closing of the transaction was not subject to the approval of Idera stockholders.
JMP Securities, a Citizens Company (JMP), is serving as exclusive strategic advisor to Idera and Morgan, Lewis & Bockius LLP is serving as legal counsel to Idera. Wedbush PacGrow is serving as exclusive strategic financial advisor to Aceragen, and Fenwick & West LLP and Hutchison PLLC are serving as legal counsel to Aceragen.
Following the acquisition, the Company has pro forma cash on hand of approximately $27 million, which is expected to provide cash runway into 3Q 2023.
Additional details are available in an updated corporate presentation that can be found online at IderaPharma.com and www.Aceragen.com.
About Idera Pharmaceuticals
Idera is focused on the acquisition, development, and ultimate commercialization of drug candidates for rare disease indications characterized by small, well-defined patient populations with serious unmet needs. Following the acquisition, the combined company will operate as a biopharmaceutical company developing innovative therapeutics for rare and orphan pulmonary and rheumatic diseases with high unmet medical need.
